Physiotherapy in Pediatric Oncology

Condition(s) studied

Investigational drug(s) / intervention(s)

Therapeutic physical exercise: Specific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises.

Therapeutic physical exercise + electrotherapy: Specific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises. Combined with the application of electrical waves for neurostimulation of the quadriceps muscles.

Therapeutic physical exercise + gamified game: Specific therapeutic exercise intervention based on FITT parameters and focusing on aerobic, anaerobic, and breathing exercises. Combined with the application of gamified exercise to improve treatment adherence in these young populations.

Study summary

The objective of this clinical trial is to determine whether therapeutic physical exercise combined with electrotherapy and exercise gaming improves rehabilitation outcomes in pediatric and adolescent cancer patients.

The main questions it aims to answer are:

Does the combination of therapeutic physical exercise plus muscle strengthening and therapeutic physical exercise plus gamification, compared to a single exercise intervention, improve patient condition? Does gamified exercise improve treatment adherence? Does electrotherapy improve muscle activity when used in muscle strengthening mode? Researchers will test the application of the described modalities and assess improvements in variables such as cardiorespiratory fitness, physical activity self-efficacy, pain, balance, joint range of motion, physical activity level, cancer-related fatigue, quality of life, anxiety-depression, sleep, kinesophobia, and social status.

Eligibility

Primary outcome measure(s)

• Strength — 6 month
  30-second sit-to-stand test to measure lower extremity muscle performance: is a functional measure of lower-limb strength in which an individual stands up and sits down from a chair as many times as possible within 30 seconds. If the test is reported using a numerical score, it corresponds to the total number of completed sit-to-stand repetitions, where the minimum value is 0, the maximum value depends on the person's performance, and higher scores indicate better lower-body strength and functional capacity.
• Cardiorespiratory function — 6 month
  6-minute walk test: is a widely used assessment of cardiorespiratory function in which an individual is instructed to walk as far as possible along a flat, measured course for six minutes. When reported numerically, the score corresponds to the total distance walked in meters, with a minimum value of 0 meters, no fixed maximum (as it depends on individual performance), and higher distances indicating better cardiorespiratory capacity and endurance.
• Physical activity self-efficacy — 6 month
  The five-item Physical Activity Self-Efficacy Scale (PASE): is a brief self-report measure that evaluates an individual's confidence in their ability to engage in physical activity under various challenging circumstances. Scores are obtained by summing responses to the five items, each typically rated on a scale from 1 (low confidence) to 5 (high confidence), yielding a minimum total score of 5 and a maximum of 25. Higher scores indicate better self-efficacy for maintaining physical activity.
• Pain level — 6 month
  Visual Analog Scale (VAS): is a simple, widely used measure for assessing the intensity of subjective experiences such as pain, fatigue, or discomfort. It typically consists of a 10-centimeter horizontal line anchored by verbal descriptors at each end-for example, 0 = "no pain" and 10 = "worst imaginable pain." The respondent marks a point on the line that represents their perceived intensity. The minimum score is 0, the maximum score is 10, and higher scores indicate a worse symptom intensity.
• Balance — 6 month
  Pediatric Berg Balance Scale (BBS): is a performance-based assessment designed to measure functional balance in children through 14 tasks such as standing, turning, and reaching. Each item is scored from 0 (inability to perform) to 4 (independent, best performance), producing a minimum total score of 0 and a maximum of 56. Higher scores indicate better balance ability and greater functional stability.
• Ankle dorsiflexion ROM — 6 month
  Goniometer: is an instrument used to measure the range of motion (ROM) of a joint. For ankle dorsiflexion, the goniometer is positioned with the axis at the lateral malleolus, the stationary arm aligned with the fibula, and the movable arm along the fifth metatarsal. Measurements are reported in degrees, with a typical minimum of 0° and a maximum depending on the individual, usually around 20° for dorsiflexion. Higher values indicate greater ankle dorsiflexion ROM, reflecting better joint flexibility.
• Weight — 6 month
  Tanita DC-439 MA
• Height — 6 month
  Harpender stadiometer
• BMI — 6 month
  weight/height 2
• Bone mineral density — 6 month
  Ultrasound (QUS Model: Bone Mineral Densiometer, (OSTEOSYS, BETTER PRODUCTS FOR BETTER LIFE, n.d.))
• Muscle circumferences (upper arm, waist, hip, and thigh) — 6 month
  Tape measure

Trial sites (1)

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